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NCT03711253 Clinical Trial

Empiric Treatment for Acute HIV in the ED

Acute HIV Infection Clinical Trial

— EMTreatED  

Official title:
Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03711253
Other study ID # APP-18-01821
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 14, 2019
Est. completion date June 1, 2023

Study information
Verified date April 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

Description:

Individuals with suspected acute HIV infection willing to start immediate ART treatment will be given the ART regimen (bictegravir 50mg + tenofovir alafenamide 25 mg + emtricitabine 200 mg fixed dose combination) on the day of diagnosis. Those patients beginning immediate ART in the ED who are willing to have additional laboratory specimens drawn in the ED and become part of a cohort to receive ART and have ongoing biological specimens obtained and will be followed for 48 weeks.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspected acute HIV infection - agree to start immediate ART and to storage of laboratory specimens Exclusion Criteria: - Known chronic HIV infection - severe renal or liver disease - drug allergy/hypersensitivity - prohibited medications - pregnancy - co-morbidity that the investigator feels would compromise safety, data interpretation, or achieving study objectives

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
antiretroviral therapy

Locations
Country Name City State
United States LA County-USC Medical Center Emergency Department Los Angeles California
United States Rand Schrader Health and Research Clinic Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acceptance of immediate ART initiation Proportion of participants that initiate immediate ART and collection of laboratory specimens at baseline for suspected acute HIV 1 day
Secondary Impact on linkage and engagement in care Proportion with immediate ART for individuals with suspected acute HIV infection with linkage and 48 week engagement in care 48 weeks
Secondary ART effects on cell associated HIV DNA Changes in cell associated HIV DNA (assays TBD based on best practices at the time of study completion) 48 weeks
Secondary ART effects leukocytes Changes in proportion of activated lymphocytes activated monocytes 48 weeks
Secondary ART effects inflammation Changes C-reactive protein levels 48 weeks
Secondary ART effects monocyte activation Changes in soluble cd14 levels 48 weeks
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